Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD
| Status: | Terminated |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 11/30/2018 |
| Start Date: | January 2016 |
| End Date: | June 2018 |
Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With Attention Deficit Hyperactivity Disorder: A Randomized Placebo-controlled Pilot Study
Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these
children have moderate to severe impairments in sleep, further exacerbating their already
impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed
sleep medications are antipsychotics that can cause marked weight gain and metabolic changes;
alternate medications have either been found to be ineffective, difficult to tolerate or are
largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms
of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive
behaviors could improve sleep patterns and this application will assess if the extension of
the therapeutic effects of CNS stimulants into the early evening improves sleep onset.
children have moderate to severe impairments in sleep, further exacerbating their already
impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed
sleep medications are antipsychotics that can cause marked weight gain and metabolic changes;
alternate medications have either been found to be ineffective, difficult to tolerate or are
largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms
of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive
behaviors could improve sleep patterns and this application will assess if the extension of
the therapeutic effects of CNS stimulants into the early evening improves sleep onset.
The goal of this application is to assess the impact of safer treatment option
Methylphenidate (MPH) on sleep and behavior problems in children with Attention Deficit
Hyperactivity Disorder (ADHD) and Behavioral Insomnia of Childhood (BIC). ADHD affects over
11% of school-aged youth. Similarly, pediatric sleep disorders occur in over a third of
children and impact multiple domains of the child's functioning as well as that of their
parents. Children with ADHD are at an increased risk for sleep problems with a staggering
comorbidity of up to 70%, while sleep deprivation worsens the already impaired social,
emotional and academic functioning of children with ADHD. Therefore, improving sleep may
translate into enhanced functioning in multiple realms. Delayed sleep onset latency (SOL) and
bedtime resistance, the key component of the limit setting type of BIC, are particularly
likely to occur in children with ADHD. Medications are commonly used for both conditions with
over 6% of all school-aged children in the United States prescribed medication for ADHD and
7% for sleep. In children with ADHD, 34% of prescribed sleep medications are antipsychotics
that can cause marked weight gain and metabolic changes. Alternate medications for sleep have
either been found to be ineffective, difficult to tolerate or are largely unstudied in youth.
MPH has an extensive database supporting their safety and efficacy. Objective sleep studies
of MPH have not found consistent results, with a few studies reporting delayed SOL and while
others report improved quality of sleep. Therefore, this proposal will evaluate the impact of
extending MPH treatment into the early evening on sleep onset using a 3-week with-in subjects
randomized trial of .3mg/kg of immediate release (IR) MPH dosed 3 hours before bedtime vs.
placebo in 38 children with ADHD and chronically delayed SOL who have a history of prolonged
stimulant usage. The investigators will recruit 38 children ages 6-12 of any gender and
racial/ethnic status with ADHD who have been treated with stable morning dose of extended
release (ER) MPH for an extended time period (30 days or more) from the primary care and
psychiatry clinics at Hershey Medical Center in Hershey, PA. Recruitment will be split into
three waves (13, 13, 12 participants). Parents will be reminded to administer the blinded
medication dose by text message each evening (or phone call by study staff) 3 hours prior to
the desired bedtime. Sleep onset will be measured by actigraphy and sleep log, with parents
also reporting on level of ODD and ADHD symptoms in the evening.
Methylphenidate (MPH) on sleep and behavior problems in children with Attention Deficit
Hyperactivity Disorder (ADHD) and Behavioral Insomnia of Childhood (BIC). ADHD affects over
11% of school-aged youth. Similarly, pediatric sleep disorders occur in over a third of
children and impact multiple domains of the child's functioning as well as that of their
parents. Children with ADHD are at an increased risk for sleep problems with a staggering
comorbidity of up to 70%, while sleep deprivation worsens the already impaired social,
emotional and academic functioning of children with ADHD. Therefore, improving sleep may
translate into enhanced functioning in multiple realms. Delayed sleep onset latency (SOL) and
bedtime resistance, the key component of the limit setting type of BIC, are particularly
likely to occur in children with ADHD. Medications are commonly used for both conditions with
over 6% of all school-aged children in the United States prescribed medication for ADHD and
7% for sleep. In children with ADHD, 34% of prescribed sleep medications are antipsychotics
that can cause marked weight gain and metabolic changes. Alternate medications for sleep have
either been found to be ineffective, difficult to tolerate or are largely unstudied in youth.
MPH has an extensive database supporting their safety and efficacy. Objective sleep studies
of MPH have not found consistent results, with a few studies reporting delayed SOL and while
others report improved quality of sleep. Therefore, this proposal will evaluate the impact of
extending MPH treatment into the early evening on sleep onset using a 3-week with-in subjects
randomized trial of .3mg/kg of immediate release (IR) MPH dosed 3 hours before bedtime vs.
placebo in 38 children with ADHD and chronically delayed SOL who have a history of prolonged
stimulant usage. The investigators will recruit 38 children ages 6-12 of any gender and
racial/ethnic status with ADHD who have been treated with stable morning dose of extended
release (ER) MPH for an extended time period (30 days or more) from the primary care and
psychiatry clinics at Hershey Medical Center in Hershey, PA. Recruitment will be split into
three waves (13, 13, 12 participants). Parents will be reminded to administer the blinded
medication dose by text message each evening (or phone call by study staff) 3 hours prior to
the desired bedtime. Sleep onset will be measured by actigraphy and sleep log, with parents
also reporting on level of ODD and ADHD symptoms in the evening.
Inclusion Criteria:
1. Ages 6-12 (inclusive), and able to swallow capsule
2. Children who have been treated with a stable morning dose of Extended Release
Methylphenidate or twice daily dose of Immediate Release Methylphenidate for an
extended period of time (30 days or longer).
3. DSM V diagnosis of Attention Deficit Hyperactivity Disorder (ADHD): Diagnosis will be
assessed on the NIMH Computerized Diagnostic Interview Schedule for Children (C-DISC),
and parent and teacher rating scales.
4. Children with any ADHD subtype meeting the above criteria will be eligible, although,
it is expected that the majority will be of the combined subtype of ADHD given the
associate between this subtype and ODD symptoms. A diagnosis of any of the two
Behavioral Insomnia of Childhood (BIC) subtypes associated with delayed SOL (limit
setting or combined type) will be required.
5. Sex: male or female
6. Fluent in written and spoken English.
Exclusion Criteria:
1. Age < 6 years of age or >12 years of age.
2. Children who have not had Methylphenidate (Extended Release) treatment for an extended
period of time (30 days or longer).
3. A diagnosis or suspicion of sleep-disordered breathing will be exclusionary as it is
not expected to be impacted by Immediate Release Methylphenidate treatment.
4. Current psychotropics other than Methylphenidate (Extended Release or Immediate
Release Methylphenidate). Children prescribed alpha agonists for adjunctive control of
ADHD in combination with a MPH product will be allowed to enroll as long as they meet
all other entry criteria (i.e. sleep must remained impaired with use of alpha
agonist).
5. Regular use of other medications that impact sleep within the last 14 days (i.e.:
sedating antihistamines, melatonin).
6. Active medical/psychiatric conditions that impact sleep (i.e.: severe asthma, Autism
Spectrum Disorder diagnosis, marked developmental delay, or mood/anxiety disorder).
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